BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-CENTESIS TRAY, 6FR X 16 CM

    MDR report key: 1822065 · Received April 5, 2010

    Report

    Report Number
    1625685-2010-00010
    Event Type
    Malfunction
    Date Received
    April 5, 2010
    Date of Event
    March 1, 2010
    Report Date
    April 1, 2010
    Manufacturer
    CAREFUSION
    Product Code
    GCB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF THE COMPLAINT SAMPLE CONFIRMED THE CANNULA OF THE (B)(4) NEEDLE WAS DISLODGED FROM THE HUB. THE NEEDLE CANNULA WAS NOT BROKEN, BUT WAS COMPLETELY REMOVED FROM THE HUB OF THE (B)(4) NEEDLE. THE INVESTIGATION NOTED THE PRESENCE OF GLUE IN THE NEEDLE HUB AREA, BUT WE WERE UNABLE TO ASSESS THE QUALITY OF THIS JOINT. THEREFORE; BASED ON THIS INFO A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. A REVIEW OF COMPLAINT DATA DID NOT IDENTIFY ANY TRENDS WITH THIS OR SIMILAR TYPES OF FAILURE MODES. A REVIEW OF ALL MFG PROCEDURES DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE OBSERVED DEFECT. THE VERESS NEEDLE IS A SUPPLIED COMPONENT THAT IS NOT ALTERED IN ANY WAY PRIOR TO PLACEMENT IN THE TRAY. THE SUPPLIER OF THE (B)(4) NEEDLE WILL BE NOTIFIED AND ALL APPLICABLE QUALITY PERSONNEL WILL BE NOTIFIED OF THIS FAILURE MODE IN AN EFFORT TO HEIGHTEN AWARENESS OF THIS TYPE OF FAILURE MODE IN REGARDS TO THE (B)(4) NEEDLE ASSEMBLY.

    Description of Event or Problem · 1

    THE NEEDLE BROKE AT THE HUB IN THE PT. THE DR WAS ABLE TO REMOVE BY HAND AND NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFE-T-CENTESIS TRAY, 6FR X 16 CM SAFE-T-CENTESIS TRAY, 6FR X 16 CM GCB CAREFUSION PIG1260T LOA191

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other